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news.US-based biopharmaceutical firm Alimera Sciences has secured marketing authorization from the Italian Medicines Agency (Agenzia Italiana del Farmaco) for ILUVIEN to treat vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
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ILUVIEN (190 micrograms intravitreal implant in applicator) has been designated a C Class product in Italy and it will be available initially to private paying patients.
The company is pursuing H Class designation for ILUVIEN with the Italian regulatory authorities, which, if granted, would expand patient access to the product.
The Italian authorization for ILUVIEN is the seventh national approval in the EU, preceded by Austria, the UK, Portugal, France, Germany and Spain.
The company said that currently ILUVIEN is commercially available in the UK and Germany.
Alimera president and chief executive officer Dan Myers said ILUVIEN has now been granted marketing authorizations in all seven EU countries in which the company initially applied.
"Additionally, we are engaged in a Repeat Use Procedure through Mutual Recognition (MRP) to obtain a positive opinion for approval from another10 EU countries," Myers said.
ILUVIEN is a sustained release intravitreal implant used to treat vision impairment related with chronic DME considered insufficiently responsive to available therapies.